Integra recalls SURG PAT XRAY 1/2X1-1/2 Model 801404 surgical patties and strips due to potential endotoxin levels in finished goods that could affect surgical safety.
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Integra is recalling surgical patties and strips with model number 801404 because they may contain higher-than-expected endotoxin levels. This could pose a risk during surgery, especially for brain and nervous system procedures.
Endotoxins are natural components of bacteria that can cause infections or inflammation when introduced into the body. Higher-than-expected levels in surgical products could lead to complications during surgery, particularly for sensitive areas like the brain.
Surgical teams using these products for brain or nervous system procedures. Patients undergoing surgery with these items are at potential risk due to endotoxin levels.
Check for model number 801404 on the packaging. Products distributed under JnJ with the same UDI numbers (10381780515005 and 20886704036521) are also included in this recall.
Look for model number 801404 on the packaging or UDI numbers 10381780515005 and 20886704036521.
The recall is due to higher-than-expected endotoxin levels in the raw materials used to produce these surgical products, which could affect surgical safety.
While the endotoxin levels may be higher than expected, the recall is for potential safety concerns during surgery, particularly for brain and nervous system procedures.
The manufacturer states that the products are safe for use but has identified a potential risk that requires recall to ensure surgical safety.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-0243-2025 — Integra Integra Hello, I own a Integra that is covered by recall Z-0243-2025 from Integra. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
